Z-0324-05

Immulite 2500 insulin Kit

Name: Z-0324-05 Immulite 2500 insulin Kit
Creator: Diagnostic Products Corp
Published: 2004-11-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-11-19 / Terminated

FDA source

Diagnostic Products Corp began a recall of Immulite 2500 insulin Kit on 2004-11-19. The reason FDA records is "Low bias of 10 to 40% at different levels of insulin in samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0324-05
Status: Terminated
Initiated: 2004-11-19
Posted: 2004-12-17
Terminated: 2005-03-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Immulite 2500 insulin Kit
Product code: CFP Radioimmunoassay, Immunoreactive Insulin
Reason for recall: Low bias of 10 to 40% at different levels of insulin in samples.
FDA root cause: Other
Action: Customers were notified by telephone on 11/19/2004. They were instructed to discard remaining kits.
Quantity in commerce: 10 kits
Distribution: Medical facilities in AK, NY, WI.
Product codes and lots: lot 102A

Product code CFP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)